Telehealth-based Symptom Management for Veterans Treated With Selinexor

Multiple Myeloma Clinical Trial

— Selinexor  

Official title:

Telehealth-based Symptom Management for Veterans Treated With Selinexor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452446
• Other study ID #: 1749975
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: June 2024
• Source: Durham VA Medical Center
• Contact: Daphne Friedman, MD
• Phone: (919) 286-0411
• Email: daphne.friedman[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to find out if continued monitoring of side effects from Selinexor and prescribed medication to prevent side effects helps improve symptoms, quality of life, and ability to continue the treatment longer.

Description:

The primary objective of this study is to evaluate control of treatment-related and cancer-associated symptoms over the first three months of therapy with selinexor in Veterans who participate in a telehealth symptom management intervention.

The secondary objectives are:

• To describe characteristics of patients treated with selinexor.

• To describe adherence with the telehealth intervention.

• To define the type and frequency of adverse events that patients experience while taking selinexor.

• To describe the duration of selinexor therapy and evaluate adherence and dose intensity of selinexor in VA cancer patients receiving a telehealth symptom management intervention.

• To describe concomitant medication usage in patients treated with selinexor.

• To assess quality of life in patients treated with selinexor in the VA.

• To estimate progression-free survival in VA cancer patients treated with selinexor.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Diagnosis of B-cell malignancy: either relapsed or refractory multiple myeloma or diffuse large B-cell lymphoma, meeting the FDA-approved indication for Selinexor treatment.

• Requiring therapy as assessed by the treating oncology provider.

• Prior authorization drug request for selinexor approved by VA oncology pharmacist.

• Subject age 18 years or older.

• Subject willing and able to perform video or telephone research visits.

• Subjects must be able to read and comprehend English.

• Subject must be a Veteran receiving cancer care from a VA facility affiliated with the National Teleoncology Program.

• Patients must be enrolled prior to starting Selinexor.

Exclusion Criteria:

• Any prior or current therapy with selinexor.

• Any medical, psychiatric, or cognitive issue that the principal investigator or the subject's oncologists believes would prevent participation or completion of the study.

• Individuals who are vulnerable to coercion or undue influence.

• Any individuals or populations that may temporarily or permanently require additional considerations include such as those susceptible to coercion or undue influence (e.g., patients with limited or no treatment options, socially and economically disadvantaged persons).

• Current selinexor therapy that is part of an investigational clinical trial.

Related Conditions & MeSH terms

• Large-cell Lymphoma
• Multiple Myeloma

Intervention

Drug:
• Selinexor
Selinexor is an oral therapy that is FDA approved for multiple myeloma and diffuse large B-cell lymphoma that have returned after prior therapy. Side effects like nausea, vomiting, and fatigue can affect how long a patient is able to continue taking Selinexor, which could mean that treatment might stop sooner.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Durham VA Medical Center	Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	• VSAS: Veteran Symptom Assessment Scale (VSAS), a cancer symptom measurement tool.	2 years
Primary	Primary Outcome Measure	• CTCAE: Common Terminology Criteria for Adverse Events, version 5.0, an adverse event measuring tool used in clinical trials.	2 years